Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tiss
Hazard
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
What You Should Do
Remedy
Urgent Medical Device Recall notification letters dated 2/14/19 were sent to customers.
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Products
Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists
- Brand
- ACell, Inc
- UPC
- SN KN000087
Units Affected
1